AMBLER SURGICAL CORP.

Address:730 Springdale Drive,EXTON,PA,19341,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Knife, ophthalmic (HNN) (9) KNIFE, EAR (JYO) (1)

Premarket Exempt

No Yes

Clear

Ambler Surgical - 10190660200272 Catalog Number : 965561

Device Description : MVR knife, 19 gauge, 1.4mm blade width, straight NexGen blade, full handle knife MVR knife, 19 gauge, 1.4mm blade width, straight NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200289 Catalog Number : 965562

Device Description : MVR knife, 23 gauge, 0.8mm blade width, straight NexGen blade, full handle knife MVR knife, 23 gauge, 0.8mm blade width, straight NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200296 Catalog Number : 965564

Device Description : MVR knife, 25 gauge, 0.6mm blade width, straight NexGen blade, full handle knife MVR knife, 25 gauge, 0.6mm blade width, straight NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200302 Catalog Number : 965565

Device Description : MVR knife, 20 gauge, 1.2mm blade width, angled NexGen blade, full handle knife, MVR knife, 20 gauge, 1.2mm blade width, angled NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200319 Catalog Number : 965566

Device Description : MVR knife, 19 gauge, 1.4mm blade width, angled NexGen blade, full handle knife, MVR knife, 19 gauge, 1.4mm blade width, angled NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200326 Catalog Number : 965567

Device Description : MVR knife, 23 gauge, 0.8mm blade width, angled NexGen blade, full handle knife, MVR knife, 23 gauge, 0.8mm blade width, angled NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200333 Catalog Number : 965569

Device Description : MVR knife, 25 gauge, 0.6mm blade width, angled NexGen blade, full handle knife, MVR knife, 25 gauge, 0.6mm blade width, angled NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200340 Catalog Number : 5700S

Device Description : Scleral blade, small European style blade, screw-in, flat stock, packaged indivi Scleral blade, small European style blade, screw-in, flat stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200357 Catalog Number : 5710S

Device Description : Scleral knife, small European style blade, full handle knife, flat stock, packag Scleral knife, small European style blade, full handle knife, flat stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200371 Catalog Number : 7100H

Device Description : Myringotomy lance knife, angled, full handle knife, flat stock, packaged individ Myringotomy lance knife, angled, full handle knife, flat stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : JYO

Prescription Use : Yes

Device Count : 1

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